Sr. Scientist I-HPLC of Biologics-3278

The job location is onsite in Kenilworth, New Jersey USA

Education: BS (+5yrs) or MS (+1yr) of relevant experience with analytical chemistry or biologics

Requirements: An analytical background with emphasis on separation-based techniques (HPLC/UPLC, SEC, IEX) and demonstrated proficiency with Empower software Knowledge of ICH requirements and how to implement them in method development and method qualification/validation Good documentation practices & utilization in electronic lab notebooks Experience in method troubleshooting and solid track record for completing laboratory-based assignments Ability to learn quickly

Ideal prior experience in analyzing biologics including monoclonal antibodies and/or other therapeutic proteins in one or more of the following techniques: Compendial tests (pH, color, clarity, particulates, etc.) UV absorbance CE-SDS High-throughput liquid handling system, e.g., Tecan, Bravo, etc. Analytical software including Softmax Pro and/or ChemStation Prior experience with method development for biologics

Day-to-day responsibilities Support of routine release/stability, in-process, and/or cell-line development testing Execution of method prequalification, qualification, and robustness for separation-based techniques Troubleshooting of method and instrument parameters when challenges arise

QualificationsEducation: BS (+5yrs) or MS (+1yr) of relevant experience with analytical chemistry or biologics

Requirements: An analytical background with emphasis on separation-based techniques (HPLC/UPLC, SEC, IEX) and demonstrated proficiency with Empower software Knowledge of ICH requirements and how to implement them in method development and method qualification/validation Good documentation practices & utilization in electronic lab notebooks Experience in method troubleshooting and solid track record for completing laboratory-based assignments Ability to learn quickly

Ideal prior experience in analyzing biologics including monoclonal antibodies and/or other therapeutic proteins in one or more of the following techniques: Compendial tests (pH, color, clarity, particulates, etc.) UV absorbance CE-SDS High-throughput liquid handling system, e.g., Tecan, Bravo, etc. Analytical software including Softmax Pro and/or ChemStation Prior experience with method development for biologics

Day-to-day responsibilities Support of routine release/stability, in-process, and/or cell-line development testing Execution of method prequalification, qualification, and robustness for separation-based techniques Troubleshooting of method and instrument parameters when challenges arise

EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.